FDA.reportPublic FDA data

MAUDE MDR 1349718

MDR report key
1349718
Report number
3004082685-2009-00002
Event key
0
Event type
3
Date of event
2009-02-17
Date received
2009-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
STEPHEN SOLOMON
Address
220 SOUTH ORANGE AVE. LIVINGSTON NJ 07039 US
Phone
973-973-9735
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMPUDENT-STAMILESTONE SCIENTIFICEJISTA5050-301UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-03-2301. O

Event Narratives#

D

Patient 1

A COMPUDENT-STA UNIT WAS USED IN CONJUNCTION WITH A WAND STA HANDPIECE TO PERFORM A DENTAL ANESTHETIC INJECTION. THE USER INSTALLED THE WAND STA HAND PIECE TO THE DRIVE UNIT AND PERFORMED A SUCCESSFUL LOWER BLOCK ANESTHETIC INJECTION. UPON REMOVING THE HAND PIECE FROM THE PATIENT'S MOUTH, THE NEEDLE SEPARATED FROM THE HAND PIECE, AND LODGED IN THE PATIENT'S BUCCALMUCOSA. THE PATIENT WAS TAKEN TO AN ORAL SURGEON, WHO WAS UNABLE TO LOCATE AND REMOVE THE NEEDLE.

N

Patient 1

THE HAND PIECE WAS NOT RETURNED TO MILESTONE FOR EVALUATION. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ACTUAL FAILURE MODE. INFORMATION FROM THE DENTIST'S INTERVIEW, A REVIEW OF THE PRODUCT LABELING AND FIELD RETURN DATA WAS USED IN THE ANALYSIS OF THIS EVENT. IN THIS CASE THE DENTIST USED A HAND PIECE WITH A 30 GAGE 1 INCH LONG NEEDLE ATTACHED. THE PRODUCT LABELING (ATTACHED) RECOMMENDS A HAND PIECE WITH A 27 GAGE 1 1/4 INCH LONG NEEDLE ATTACHED FOR THIS TYPE OF AN INJECTION. WITHOUT THE ACTUAL HAND PIECE, IT CANNOT BE DETERMINED IF THE USE OF THE SHORTER, THINNER NEEDLE CONTRIBUTED TO THIS ADVERSE EVENT. HOWEVER, THE USE OF A SHORTER NEEDLE WOULD MAKE RECOVERY OF THE NEEDLE MORE DIFFICULT. SEE SCANNED PAGE.